FDA 510(k) Application Details - K040727

Device Classification Name Powered Laser Surgical Instrument

  More FDA Info for this Device
510(K) Number K040727
Device Name Powered Laser Surgical Instrument
Applicant ZIMMER ELEKTROMEDIZIN GMBH
JUNKERSSTRASSE 9
NEU-ULM D-89231 DE
Other 510(k) Applications for this Company
Contact STEFAN LEINWEBER
Other 510(k) Applications for this Contact
Regulation Number 878.4810

  More FDA Info for this Regulation Number
Classification Product Code GEX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/22/2004
Decision Date 04/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact